Gxp jobs in newark, ca

Hybrid in San Francisco, California

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9d ago

Job Title: GxP Project Manager Location: Bay Area, CA Duration: 6+ months with possible of extension Required Qualifications Bachelor's degree in Engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or related field.8+ years of Project Management experience within the Pharmaceutical or Biotechnology industry.5+ years managing GxP-regulated projects.Strong understanding of GMP, GxP, GAMP 5, FDA regulations, and 21 CFR Part 11.Experience managing Computer System Validation (CSV)

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Third Party, Contract

$80 - $90

GXP Project Manager

Hybrid in San Francisco, California

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13d ago

About Nexinfo NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. We offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. We aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Our ERP-related services address challenges such as inven

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Contract, Third Party

$70 - $80

GxP Systems and Support Administrator

Remote

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Today

Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose inform

Full-time

USD 130,000.00 - 150,000.00 per year

Program Manager with BA

Foster City, California

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2d ago

Role:Program Manager with BA Location:Foster City CA Fulltime Primary (Must have skills)*8+ years of experience in PM / Business Analysis with LifeScience domain 6+ Strong understanding of SDLC, support processes, and ticket managementworkflows. 4+ Experience with Azure DevOps (ADO)for activity tracking and project management. Strong stakeholder management, communication, and facilitation skills. Experience gathering and documenting business requirements and process flows. Ability to manage mul

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Full-time

Depends on Experience

Project Manager (Veeva Vault Clinical DR Validation Support) -Fulltime Role

Foster City, California

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28d ago

Senior Project Manager Vault Clinical DR ValidationFosters City CA Onsite - Full TImeExperience Range: 10-20 yearsIdeal candidate will have domain from Life Sciences, Pharmaceutical, Biotechnology, or Healthcare ( Not Healthcare Insurance)Primary skills(Must have skills)10+ years of Project Management experience,Experience in Disaster Recovery / DR project planning and coordinationExperience managing complex technical projects involving Project planning, scheduling, and milestone trackingRisk,

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Full-time

130,000 - 140,000

Sr. Computer Systems Validation Analyst

Foster City, California

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14d ago

Summary : We are seeking a Senior Computer Systems Validation (CSV) Analyst with strong experience in GxP-regulated pharmaceutical/life sciences environments. The candidate will be responsible for planning, leading, and executing validation activities for SCADA, Rockwell FactoryTalk, PLCs, and Ignition process control systems. The role requires hands-on expertise in GAMP 5, 21 CFR Part 11, EU Annex 11, validation lifecycle documentation, risk assessments, change controls, and qualification prot

Full-time

Senior / Staff Data Integrity Engineer (Compliance) #4942

Sunnyvale, California

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Today

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scal

Full-time

USD 135,000.00 - 180,000.00 per year

Site Reliability Engineer

Hybrid in Sunnyvale, California

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2d ago

Job Title: Site Reliability Engineer Location: Sunnyvale, CA - Hybrid (Onsite 3 days a week) Position Summary:As Staff Site Reliability Engineer Engineer, you will serve as a technical individual contributor responsible for supporting architecture, securing, and sustaining the production infrastructure supporting our regulated digital health and medical software platforms. You will ensure reliability, scalability, and compliance of critical systems in alignment with FDA GxP guidelines and HITR

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Contract

75 - 80

AI Platform Engineer

San Jose, California

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Today

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Life Sciences, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - i

Full-time

USD 150,000.00 - 200,000.00 per year

Validation Analyst

Hybrid in San Francisco, California

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Today

Role Overview Seeking an experienced Validation Analyst to support Roche's GIP program, focusing on validation of medical imaging applications, AI/ML workflows, and the Algorithm Workbench platform. The role will ensure system quality, regulatory compliance, data integrity, and end-to-end validation readiness. Key Responsibilities Develop and execute Computer System Validation (CSV) deliverables, including validation plans, risk assessments, IQ/OQ/PQ protocols, and validation summary reports.

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Full-time

60 - 70

Salesforce Marketing Cloud Technical Consultant / Lead

Alameda, California

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Yesterday

Position: Salesforce Marketing Cloud Technical Consultant / Lead Location: Alameda, CA (Onsite) Duration: 06 Months (Extendable) 4-8 years of experience. Salesforce Marketing Cloud, CRM platforms. Must have: Experience supporting campaign execution, platform optimization, integrations, and reporting. Fully involved in Marketing Function, skilled in Marketing Cloud Development as well. Must Report to Client Alameda, California Office Role Descriptions: Strong working knowledge of Sales Cloud

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Contract, Third Party

50 - 60

Validation Analyst

Hybrid in San Francisco, California

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Yesterday

Job Title: Validation AnalystProject: Medical Imaging & Algorithm Workbench Location: San Francisco, CA Work Model: Hybrid 4 Days Onsite Role OverviewWe are seeking an experienced Validation Analyst to support Roches GIP program, focusing on the validation of medical imaging applications, AI/ML workflows, and the Algorithm Workbench platform. The ideal candidate will ensure system quality, regulatory compliance, data integrity, and end-to-end validation readiness while supporting software rele

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Contract, Third Party

70 - 80

Director, IT Data and AI Product Owner - Clinical Development

Foster City, California

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Today

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Full-time

USD 226,185.00 - 292,710.00 per year

Sr. Manager, Operational Technology Programs & Operations Excellence

Newark, California

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Today

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics, and biotechnology? At Cepheid, one of Danaher's 15+ operating companies, our work saves lives, and we're all united by a shared commitment to innovate for tangible impact. You will thrive in a culture of belonging where you and your unique viewpoint matter. By harnessing Danaher's system of continuous improvement, you help turn ideas into impact, innovating at the speed

Full-time

USD 165,000.00 - 196,000.00 per year

US_Software Engineer II_CO

South San Francisco, California

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Today

Job Title: Software Engineer II Job Location: San Francisco California 94080 Job Duration: 12 months with possible ext Position Summary Early Development (gRED), within Early Clinical Development Informatics (ECDi), is seeking an experienced Software Engineer to design, develop, and optimize tools and platforms that accelerate clinical trial development and help bring life-changing medicines to patients faster. In this role, you'll work with engineers, analysts, and business stakeholders to t

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Contract

$76 - $76.51

Director, AI Systems Quality & Governance, R&D

Foster City, California

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Today

Full-time

USD 210,375.00 - 272,250.00 per year

Agentic Automation Lead - Frontier AI

South San Francisco, California

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Today

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but i

Full-time

USD 193,500.00 - 338,800.00 per year

SAP Validation

Remote

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23d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

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Contract

Depends on Experience

Project Manager/ Business Analyst (Clinical Operations)

Hybrid in Foster City, California

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2d ago

Job Title: Project Manager/ Business Analyst (Clinical Operations) Location: Foster City, CA (Hybrid)Employment Type: Full-Time (FTE) Job SummarySeeking a Senior Project Manager / Business Analyst with strong Clinical Operations expertise and hands-on experience in Risk-Based Monitoring (RBM/RBQM). Responsible for requirements gathering, project delivery, stakeholder management, and implementation of clinical systems and monitoring processes. Key ResponsibilitiesLead requirements gathering for R

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Full-time

$160,000 - $160,000

Business Systems Analyst III

Remote

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6d ago

Business Systems Analyst LMS Transformation & SAP SuccessFactors Learning Migration Sumtotal LMS experience is required. 12 month remote contract. $40 an hour w2. No C2C or 1099 at this time. EST or CST candidates preferredPosition SummaryMilestone is seeking an experienced Business Systems Analyst (BSA ) to support the enterprise Learning Management System (LMS) transformation initiative, including the migration from SumTotal LMS to SAP SuccessFactors Learning. The BSA will serve as the li

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Contract

Depends on Experience

Gxp jobs in Newark, CA 94560, USA